FDA Adverse Event
Malfunction
Summary report: N
XIA LP POLYAXIAL SCREW 7.5 X 60MM
MDR report key: 1193506
·
Received October 8, 2008
Report
- Report Number
- 9617544-2008-00118
- Event Type
- Malfunction
- Date Received
- October 8, 2008
- Date of Event
- August 27, 2008
- Report Date
- August 27, 2008
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- KWQ
- PMA / PMN Number
- K060361
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF PROVIDED, WILL BE REPORTED ON A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE PROVIDED ON A SUPPLEMENTAL FOLLOWING ENGINEERING EVALUATION.
Description of Event or Problem · 1
DURING THE REVISION SURGERY, THE SURGEON TRIED TO MOVE THE SCREW HEAD FOR A SMALL ADJUSTMENT USING A DRIVER. THE SCREW DISASSEMBLED THUS THE SCREW HAD TO BE REMOVED AND REPLACED WITH A NEW SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA LP POLYAXIAL SCREW 7.5 X 60MM | IMPLANT | KWQ | STRYKER SPINE BORDEAUX | NA | 034028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |